Marketing Authorisations

The Icelandic Medicines Agency (IMA) issues a letter of approval in regards to new marketing authorisations, renewals, line extensions, withdrawals, suspensions and lifting of suspensions. In general, variations are considered automatically approved in Iceland at the same time as in the EU Member States. Consequently IMA does not issue letters of approval regarding for example for new indications and new presentations. However, IMA issues a letter of approval when a variation leads to new conditions or restrictions with regard to the safe and effective use of the medicinal product to be fulfilled before marketing in a Member State or when those conditions are changed from the ones previously fulfilled by the marketing authorisation holder. IMA also issues a letter informing the marketing authorisation holder if a variation effects the prescription status of the medicinal product in Iceland. (21.9.2015)

2. Does the Icelandic Medicines Agency (IMA) assess product names before an application is submitted?

No, IMA assesses product names during the application procedure.

(2.9.2015)

3. What rule/guidlines does the Icelandic Medicines Agency (IMA) use for assessing product names?

6. When applying for a marketing authorization for a generic product and part of the indications are protected by patent, is it necessary to submit Icelandic translation of the whole English product information as approved in the registration procedure or omit (carve out) the patented indications?

IMA always requests an Icelandic translation of the whole English product information as approved in the procedure. The marketing authorization is granted including the Icelandic translation of the whole English product information approved in the registration procedure. If the applicant wishes to carve out patented indications, he should apply for a national variation with the following grouping: C.I.6 Change(s) to therapeutic indication(s), Procedure type IB, Deletion of a therapeutic indication. It is the responsibility of the applicant to carve out all information in the product information (SmPC, Package leaflet and labelling) that relates to the patented indication. When the applicant wishes to add the carved-out indication(s) after patent expiry, he should do so with a national application with the following grouping: C.I.z, Change(s) to therapeutic indication(s), Procedure type IA, Addition of carved indications. Then it is only allowed to change back to the originally approved product information.

(13.4.2016)

7. How is the sunset clause
used in Iceland?

The Sunset Clause in Directive 2001/83/EC was implemented in
Article 7 of the Pharmaceutical Act No 93/1994: “The marketing authorisation
is invalidated if the medicinal product for which the marketing authorisation
is granted has not been placed on the market within three years of the granting
of the authorisation, or if a medicinal product for which authorisation has
been granted, and which has been placed on the market, has not in fact been on
the market for a continuous period of three years. The Medicines Agency may
grant exemptions from this provision in special circumstances, and for reasons
relating to public health. Such exemptions shall be supported by valid reasons.”

The Icelandic Medicines Agency, IMA, is of the opinion that
applying the sunset clause could counteract the necessary increase of marketed
medicinal products in Iceland. Hence IMA has decided not to enforce the sunset
clause for the time being. Marketing authorisation holders will be informed
should this decision be amended.

The Icelandic Medicines Agency follows EMA‘s linguistic review process of
product information in the centralised procedure. However, from 10 November
2018, the Icelandic Medicines Agency postpones the review of changes for
medicinal products not marketed in Iceland until released. The Icelandic
product information for new products will still undergo a linguistic review,
and therefore the postponement only applies to changes to the product information for products not marketed in
Iceland. Product information for products sold on special licence undergoes
linguistic review, as applicable. Product information for centrally authorised
originator products, not on the Icelandic market, will undergo a linguistic
review if a centrally authorised generic product is on the Icelandic market. When
a product is marketed in Iceland, the Icelandic Medicines Agency will use the
first opportunity to review the changes made from the last review of the
Icelandic product information.

(9.11.2018)

MAH transfer

1. Transfer of a marketing authorisation for a medicinal product to a third party – applies to national, as well as DCP and MRP authorisations.

The same application form shall be used when applying for a transfer of a marketing authorisation to a third party as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.

In order to support an application for an approval of a new marketing authorisation holder (MAH) a signed statement shall be submitted from competent representatives of the current as well as the prospective MAH (the same form may be used), as well as an updated SmPC and PIL, in accordance with general rules. Mock-up of an updated PIL, as well as updated packages shall be sent to the Icelandic Medicines Agency (IMA), when available, but still within the time-limit set out in a formal letter from the Agency.

The statement shall include the date from which the new MAH takes over all duties related to the medicinal product, i.e. from the date the transfer of the marketing authorisation comes into effect.

If the prospective MAH does not have a medicinal product with a marketing authorisation in Iceland, a description of the MAH´s pharmacovigilance system shall also be supplied. The statement should also contain the name of an Icelandic representative of the new MAH as well as of a wholesale distributor for the Icelandic market (if applicable).

2. Upon transfer of Marketing Authorisation for a medicinal product who shall apply for the transfer: the current or the proposed Marketing Authorisation Holder?

It is up to the current and proposed Marketing Authorisation Holders to decide which one of them submits the application provided the application contains all the required documentation (see question 1).

(24.11.2016)

3. What is the estimated IMA´s timeframe for approval of a Marketing Authorisation Holder transfer?

IMA‘s goal is to handle the application as soon as possible and in most cases within one month from receiving the application provided it contains all the required documentation.

(24.11.2016)

4. Once the MA is transferred to the new owner, for how long can stocks be sold using the details of the previous MA holder?

Generally if the medicinal product has been released for sale on the Icelandic market, it is permitted to stay there for up to 12 months. IMA requests updated mock-ups and PILs within a year from the time the MA transfer has been granted. IMA expects updated packages to be available on the market within 12 months. If a situation arises where it is foreseen that one year will not be sufficient to sell old supplies the MA holder can apply to IMA for an extension which will then be assessed on a case-by-case basis.

(24.11.2016)

5. Notification of a new representative – applies to all types of authorisation procedures

The same application form shall be used when notifying a new representative as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.

If the application covers two or more medicinal products only one form needs to be filled out if the application only relates to nationally authorised medicinal products. If the application also covers DCP, MRP and centrally authorised medicinal products a separate form must be completed for each procedure, where one form for two or more medicinal products is also sufficient.

The concerned medicinal products can either be listed in the appropriate places on the form itself or a reference can be made to an annex to the form, in which case the annex must contain all the information stipulated in the application form.

Along with the notification of a new representative there shall be a proposal for an updated PIL for nationally, DCP and MRP authorised medicinal products, in accordance with general rules. A mock-up of an updated PIL, as well as updated packages, if applicable, shall be sent to IMA, when available, but still within the time-limit set out in the formal letter from the Agency.

It is anticipated that PILs for centrally authorised medicinal products will be updated in connection with the EU Commission´s update of the same information and then consequently a mock-up would be sent to the Agency.

The MAH shall send the above-mentioned application to the Agency, but in case somebody else does it a statement from the MAH shall be appended to the application specifying who is authorised to apply for the change and which change it covers. The application must have reached the Agency at least one month prior to the anticipated change to come into effect.

6. Can a change in MA transfer application be submitted while variations affecting the medicinal product are still pending?

Yes, after the transfer has been approved the new MAH will receive answers for the variation application that were still unfinished at the time the transfer was approved.

(4.10.2017)

7. Is it possible to submit any variations while there is an ongoing MAH transfer procedure?

Yes.

(4.10.2017)

8. What does a transfer of a marketing authorisation to a new MAH cost?

9. Who is responsible for the payment of a MAH transfer? Current or proposed MAH?

It is up to the applicant where the invoice will be sent and should be stated in the application form.

(4.10.2017)

Importation by Individuals of Medicinal Products for Personal Use

1. Am I allowed to buy medicinal products on the internet?

Yes, a person is permitted to buy medicinal products from a pharmacy within the EEA that has license to sell medicinal products online. The import has to fulfil all provisions and restrictions in regulation No. 212/1998 on importation by individuals of medicinal products for personal use, stated in the answer to questions No. 2, 3, 5, 6 and 7.

2. How do I know which pharmacy within EEA has license to sell medicinal products on the internet?

There is currently no licensed Icelandic pharmacy that operates an internet pharmacy.

The European Union has introduced a common logo that should appear on the websites of licensed pharmacies in the 28 EU Member States. Further information regarding the common logo can be found on the European Commission´s website: http://ec.europa.eu/health/human-use/eu-logo/index_en.htm

3. Am I allowed to have medicinal products sent by mail from a licensed pharmacy and are there any restrictions on quantity?

Yes, an individual can import medicinal products for his/her personal use through the mail from European Economic Area (EEA) states in a quantity equivalent to no more than 100 days use.

The import must fulfill requirements set out in Regulation No. 212/1998 (see answers to questions No 5-7 below).

4. When travelling to Iceland, can I bring medicinal products for personal use in my luggage?

An individual may bring medicinal products for his/her personal use in a quantity equivalent to no more than 100 days ‘use when entering Iceland.

5. What are the requirements I have to fulfill to import medicinal products for personal use to Iceland?

A person that imports a medicinal product to Iceland can be requested to verify that the medicinal product he or she intends to import for personal use has been acquired by legitimate means and that the medicinal product is necessary for the individual in the amount specified.

For information on restrictions of imported amounts of medicinal products (see answers to questions No 3 and 4 above). Restrictions on import of narcotic, psychotropic, anabolic steroids and growth hormones also apply in regulation No. 212/1998 (see answers to questions No 6 and 7 below).

6. What are the restrictions for importing narcotic and psychotropic medicinal products?

In the case of medicinal products covered by the provisions of the Act and Regulations on Habit Forming and Narcotic Substances No. 65/1974 and No 233/2001, respectively, and which are included on lists N-I, N-II, N-III and N-IV of the International Convention on Narcotic Drugs of 1961 and lists P-I, P-II and P-III of the International Convention on Psychotropic Substances of 1971 to which Iceland is a party, the following shall apply to their importation:

An individual who is resident in a country which is a member of the Schengen Treaty may take along medicinal products, for personal use and which have been prescribed in a legitimate manner, equivalent to up to 30 days use. The same shall apply to individuals resident outside the Schengen area, except that they may only take along medicinal products for 14 days use.

Medicinal products covered by these provisions may not be imported through mail.

7. What are the restrictions for importing anabolic steroid type (anabolica) and similar substances and growth hormones and comparable substances?

An individual may not import anabolic steroid type (anabolica) and similar substances and growth hormones and comparable substances either in personal luggage or by other means in excess of the quantity required by an individual for a maximum of 30 days.

Customs authorities may request that an individual in possession of anabolic steroid type (anabolica) and similar substances and growth hormones and comparable substances provides satisfactory proof that these medicinal products are necessary to the individual in the quantity specified, e.g. by means of a physician's certificate.

Pharmacovigilance

1. What happens to ICSRs received by IMA from healthcare professionals and the public?

ICSRs received by IMA are assessed and then submitted to the European Medicines Agency via EudraVigilance and to the World Health Organization (WHO).

2. Is there a list of local literature that the Marketing Authorisation Holders should monitor?

IMA does not have a preferred list, but the Icelandic Medical Journal (Læknablaðið) should be monitored as a minimum.

3. Does IMA require literature reports for Icelandic cases? Should a copy of the literature article be attached?

Marketing Authorisation Holders should report literature cases to EMA through EudraVigilance and IMA can access them in the database. Generally, IMA does not require a copy of literature articles, however IMA may request these.

4. Are Marketing Authorisation Holders required to have a Qualified Person for PharmacoVigilance (QPPV) residing in Iceland?

IMA does not require Marketing Authorisation Holders to have a QPPV residing in Iceland, however, the QPPV must be located within the EEA.

5. Are Marketing Authorisation Holders required to have a Local Contact Person for Pharmacovigilance in Iceland?

No, Marketing Authorisation Holders are not required to have a Local Contact Person for Pharmacovigilance in Iceland.

6. How long is there an obligation to continue collection and submission of spontaneous ADR reports after a marketing authorisation of the suspect product was withdrawn?

According to GVP Module VI section VI.C.2.2.8. marketing authorisation holders are encouraged to receive and collect all adverse events/adverse drug reports, irrespective if the license for a medicinal product is withdrawn or not, and report them to EMA.

7. How long is there an obligation to create and submit PSURs or RMPs after a marketing authorisation was withdrawn?

After a marketing authorisation is withdrawn there is no requirement for submission of a PSUR with the exception of withdrawn products with conditions/restrictions with regard to the safe and effective use of the medicinal product, in such cases the IMA requires submission of a PSUR.
When a product is withdrawn there are no obligations to create or update an RMP in the dossier for the withdrawn product. However, GVP Module V states the following „For an individual marketing authorisation holder and applicant, all products containing the same active substance should be included in one RMP [IR Art 30(2)] unless separate presentations are requested by the competent authority or agreed by the same at the request of the applicant/marketing authorisation holder.“ Therefore, if the relevant RMP covers other products than the withdrawn one, the RMP needs to be updated to reflect that one product was withdrawn. The dossier for each product (apart from the withdrawn product) needs to be updated accordingly at the next regulatory opportunity.

Compassionate use / exemption to use an unauthorised product

1. How are products prescribed for compassionate use handled in Iceland?

Products prescribed for compassionate use are handled via the same procedure as products granted named-patient basis use exemptions (exemptions granted under exceptional circumstances to physicians to use a product which does not have a marketing authorisation in Iceland).

This is in accordance to Article 7(7) of the Medicinal Product Act No 93/1994: „The Icelandic Medicines Agency may, under exceptional circumstances, grant a physician, upon his/her personal responsibility, an exemption from paragraph 1 for medicinal products which do not have marketing authorisation in Iceland. In granting such exemptions, care shall be taken to ensure that the amount of the medicinal products is limited to the needs of those for whom they are intended.“

Products with Icelandic marketing authorisation but not marketed in Iceland are handled via the same procedure.

(31.8.2016)

2. Are there any restrictions?

The amount of the medicinal products is limited to the needs of those for whom they are intended. In general an exemption would not be granted if an authorised product that can be used is marketed in Iceland.

(31.8.2016)

3. Are there special requirements regarding labelling?

No. When applying for a named-patient basis use or hospital-basis use the physician takes responsibility of the product, including labelling and PIL.

(31.8.2016)

4. Must the product be provided free of charge?

No.

(31.8.2016)

5. Who is responsible for making the request?

A physician applies for the use of a product. It can allow up to one year's use of the product. The approval is sent to the patient or pharmacy (an approved prescription) and to the wholesaler who will import the medicinal product.

(31.8.2016)

6. Can an application be made for a group of patients?

A physician might apply for the use in a hospital or a specific hospital ward. However, this would never be the case for products that do not have marketing authorisation anywhere.

(31.8.2016)

7. How long does it take to get an approval?

Most applications are dealt with immediately and processed within the same workday. However, first instance applications for medicinal products applied can take longer.

(31.8.2016)

8. How long does the approval last and can it be renewed?

The approval can last for up to one year. Then a physician will have to apply again using the same procedure.

(31.8.2016)

9. Does the product need to be licenced somewhere in the EU?

There is be a possibility, in special circumstances, to allow the use of a product with that has not been authorised in the EU and possibly even no license at all.

(31.8.2016)

10. Are pharmacies able to hold stock of these products?

Pharmacies can only buy these products from a wholesaler when they have a valid prescription (an application approved by the Icelandic Medicines Agency).

11. Are there any rules and restrictions for import?

There are no specific reporting obligations – general reporting rules are valid.

(31.8.2016)

13. What happens when a product becomes commercially available in Iceland? Does all „compassionate“ supply finish immediately or is there any period to allow a patient to move from a compassionate to a commercial supply of the drug?

Generally, no applications would be approved for the compassionate use supply after the product becomes available. However, in most cases already approved applications would still be valid (for up to a year).

(31.8.2016)

Annual fees

1. I received an invoice for annual
fees, why am I charged for such fees ?

The marketing authorisation holder shall, in accordance with Annex I to
Tariff no. 250/2017, pay an annual fee pursuant to Article 3, Para.4&5 of
the Medicinal Products Act No 93/1994 for each pharmaceutical form and strength
of a proprietary medicinal product, a parallel-imported medicinal product, a
herbal medicinal product and a medicinal product pursuant to Article 8, Para.2
of the Medicinal Products Act, which has a marketing authorisation on 1 January
each year.

The annual fees are inter alia intended to cover the maintenance of the
drug catalogues, the registration of adverse reactions and the information
service in respect of medicinal products which have a marketing authorisation
in Iceland, as well as expenses resulting from necessary co-operation with
foreign agencies in respect of medicinal products that have already been
granted marketing authorisations in Iceland.

If the marketing authorisation holder does not reside in Iceland, his
national representative is responsible for paying the annual fee.

A completed application form must be sent together with a cover letter
from the applilcant to IMA after 1 January and no later than 20 January each
year. No discount will be granted for applications received by IMA after that
time. Each cover letter may accompany application forms for medicinal products
from the same marketing authorization holder. Each application form can cover
all strengths of one pharmaceutical form.
The application form must contain information about the turnover of the produc
for the last 2 years. The turnover refers to the aggregate value of all
packages of all formulations and the strength of the product concerned, without
VAT.

2. The list of IMA´s fees is in
ISK, can I get this list in EUR ?

IMA doesn´t issue a list of fees in
EUR. However – when you receive inovoces from IMA the invoice´s amount is
stated both in ISK and EUR on the invoice.

(09.11.2017)

3. How do I pay for an application/variation
that has been submitted to IMA ?

After your application/variation has been reviewed and registered into
our database, you will receive an invoice. The invoice contains all the
information required to make a payment.

(09.11.2017)

4. Can I pay in advance for an
application/variation that has been submitted to IMA ?

No, do not send a payment for
application/variation in advance. If you do so we have no invoice to record the
payment on and the payment could get lost in the system. Only pay when you have
received an invoice from IMA.

(09.11.2017)

5. How do I receive an invoice from
IMA ?

Invoices from IMA are sent by mail. If customers prefer to receive
invoices in PDF by email for a faster delivery, please contact: sbn@ima.is

(09.11.2017)

6. What determines to whom the
invoice is addressed to ?

In the application form (in the signature section) is a field for
payment information „Billing address (when relevant)“.

IMA´s issues the invoices to the address which is stated in the field
„Billing address (when relevant)“. If there is no address stated in the abovementioned
field the invoice is sent to the representative or the marketing authorization
holder. Therefore, it is important that the information stated in the field
„Billing address (when relevant)“ are correct.

(09.11.2017)

7. What are IMA´s payment terms for
invoices ?

IMA´s payment terms are 30 days from the invoice date.

(09.11.2017)

8. The amount of IMA´s invoice is
in ISK, can I pay in EUR ?

IMA is an Icelandic public institution and therefore we can only issue
invoices in local currency.

However for optimization for our customers we have added a recalculation
from ISK to EUR to our invoices. So the invoice´s amount is stated both in ISK
and EUR on the bottom of our invoices:

Invoice no.

77703

Due ISK:

52.000

Exchange rate:

124,70

Due EUR:

417,00

Please pay in EUR

Payment terms:

30 days

Please note that the above calculation can cause the invoice to be on 2
pages and can be visible on the backside of the invoice.

10. Can I request for an accelerated procedure for an application/variation?

Yes, it is possible, but a double fee for
application/variation will be charged.

(09.11.2017)

11. What is IMA´s VAT number ?

In Iceland healthcare service is exempt from VAT and therefore IMA
doesn´t have a VAT number. IMA has an organization number: 08317 and a social
security number: 670900-2740 which can be used as an ID number.

(09.11.2017)

12. I have made a payment to an
invoice but it was returned, what shall I do ?

16. IMA´s invoice is in Icelandic,
can you translate it for me ?

Cannabis

Yes. The
medicinal product Sativex (contains THC and CBD) has a marketing authorization
in Iceland. Sativex can be bought in a pharmacy with prescription from
physicians who are specialists in neurological diseases.

Physicians
in Iceland can apply for other medicinal products which contain THC and/or CBD
if they have valid marketing authorizations in other countries. The physician
needs to justify why the patient cannot use other medicinal products with marketing
authorizations in Iceland.

(22.03.2018)

2. Why does only one medicinal product
containing cannabis have a marketing authorization in Iceland?

IMA can
only grant a marketing authorization for a medicinal product if the marketing
authorization holder applies for it in
Iceland.

(22.03.2018)

3. Is
it legal in Iceland to sell medicinal products that contains cannabis (e.g. CBD or THC) in a retail store or in internet
stores?

No, in
Iceland the main rule is that medicinal products are sold in pharmacies and
that medicinal products must have marketing authorizations in Iceland, in
accordance with the Medicinal Products Act No. 93/1994. Furthermore, cannabis
is prohibited within the Icelandic territorial jurisdiction, except for special
exemptions according to the Habit-forming and Narcotic Substances Act No.
65/1974.

(22.03.2018)

4. Is it legal in Iceland to sell food
supplements that contain CBD in a store and/or in internet stores?

If a product
is manufactured and marketed as a food supplement and/or imported as such, the
product and the import must be according to Icelandic food regulation. The
Icelandic Food and Veterinary Authority is the competent authority for food on the
Icelandic market.

(22.03.2018)

5. Is it legal in Iceland to buy or
sell THC-oils in a store and/or in internet stores?

No, THC is
a substance which is prohibited in Icelandic territorial jurisdiction with
special exemptions cf. Article 2 of the Act on Habit-forming and Narcotic
Substances, No 65/1974

(22.03.2018)

6. According
to information that can be found on the internet it is legal to sell CBD oils
that contain less than 0,2 % of THC. Is this information right?

No, in
general this statement, and other similar, are wrong. Every country sets its
own rules on the level of THC permitted in a product. In Iceland the Act on
Habit-forming and Narcotic Substances, No 65/1974 does not permit any THC in
products except in special medicinal products with marketing authorizations.

(22.03.2018)

7. Why does a product that contains CBD and is
manufactured as food supplement have to fulfil same restrictions as a medicinal
product in Iceland?

According
to paragraph 2 of Art.5 of the Medicinal
products Act No. 93/1994 the Icelandic
Medicines Agency shall decide if there is a doubt as to whether individual
substances or compounds are medicinal products. In case of doubt as to whether
a product can, taking into account all its properties, fall within the terms of
definition of a medicinal product, and the definition of a product subject to
other legislation, the provisions of Medicinal products Act shall apply.

The
medicinal product Sativex has a marketing authorization in Iceland and one of the
two active ingredients is CBD.

If a
product has an ingredient that is an active ingredient in a medicinal product which
has a marketing authorization there is the abovementioned doubt and the product
has to fulfil same restrictions as other medicinal products to be legal on the
Icelandic market.

(22.03.2018)

8. Can I import to Iceland CBD oil for
personal use through mail or in my luggage?

Yes, an individual can import CBD for his/her
personal use through mail or in his/her luggage if the CBD is manufactured
as a medicinal product. The import needs to be according to regulation No.
212/1998 on importation by individuals of medicinal products for personal use.

A person that
imports a CBD to Iceland can be requested to verify that the medicinal product
he or she intends to import for personal use has been acquired by legitimate
means and that the CBD is necessary for the individual in the amount specified.

(22.03.2018)

9. Can an individual import a product containing
CBD that is manufactured and marketed as a food supplement?

If a
product is manufactured and marketed as a food supplement the import must be
according to Icelandic food regulation, the Icelandic Food and Veterinary
Authority is the competent authority.

(22.03.2018)

PSUR

1. Does
the submission of the PSUR via common repository within 70/90 days fulfil IMA’s
requirements?

Yes. On 13th of June 2016 the PSUR Repository became mandatory. This means
that marketing authorisation holders must use the PSUR repository as a single
point for all submissions and should no longer submit PSURs to NCAs
(national competent authorities) directly.